Response by Deharo et al to Letter Regarding Article, "Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis: Data From a Nationwide Analysis".
Response by Deharo et al to Letter Regarding Article, "Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis: Data From a Nationwide Analysis".
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Deharo 等人对有关文章“Sapien 3 球囊扩张型与 Evolut R 自扩张型经导管主动脉瓣植入对主动脉瓣狭窄患者的影响：来自全国范围分析的数据”的回复。
DOI：
10.1161/circulationaha.120.047271
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发表时间：
2020
期刊：
影响因子：
37.8
通讯作者：
L. Fauchier
中科院分区：
文献类型：
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作者：
P. Deharo;A. Bisson;C. Saint Etienne;L. Fauchier
循环。2020;141:e912-e913。Pierre Deharo， MD, Arnaud Bisson， MD, Christophe Saint Etienne， MD, Laurent Fauchier， MD, PhD .回复：我们仔细阅读了Abbas博士对我们的论文的评论，该论文是关于气球可膨胀与自膨胀经导管主动脉瓣植入对法国主动脉狭窄患者的影响我们可能同意经导管主动脉瓣置换术（TAVR）后超声心动图梯度、面积和泄漏的临床影响充其量是有争议的，但这一评论并不直接适用于我们的研究。我们的研究基于行政数据，其中包括使用国际疾病分类- 10和法国医疗程序分类编码的诊断信息。我们的分析仅限于数据库中存在的变量，这意味着超声心动图特征，如平均梯度、瓣膜面积、钙化和瓣旁泄漏无法用于分析，并且我们没有对阿巴斯博士提到的问题进行假设。同样地，在“超声心动图梯度……”这样的语句中加入我们的参考文献也是不合适的。因为我们只纳入了使用新一代设备（Evolut R和Sapiens 3）治疗的患者，因此不能转化为有临床意义的结果。在我们的评论中，我们只提出了一种可能的解释，即使用自膨胀瓣膜的心力衰竭再次住院的高风险可能与其他使用自膨胀瓣膜的人经常报告的较高的瓣旁漏率有关我们同意经导管主动脉瓣置换术后的超声参数仍然只是预测临床结果的替代终点。我们庞大的人口使我们能够分析死亡率，这是心脏介入手术后的最终终点。我们希望我们的信息尽可能明确。我们的分析包括了用于经导管主动脉瓣置换术的最新一代球囊膨胀性瓣膜与自膨胀性瓣膜的最大队列。气球扩张技术与较低的硬临床终点（全因和心血管死亡，以及心力衰竭再住院）发生率相关，超出了任何超声心动图终点的分析。就我们的研究而言，将我们的结果说成是“在调整了超声心动图上的瓣旁泄漏后，尽管球囊可膨胀瓣膜与自膨胀瓣膜的残余梯度更高”是不准确的。
Circulation. 2020;141:e912–e913. DOI: 10.1161/CIRCULATIONAHA.120.047271 e912 Pierre Deharo, MD, PhD Arnaud Bisson, MD Christophe Saint Etienne, MD Laurent Fauchier , MD, PhD In Response: We read with attention the comments by Dr Abbas about our paper on the impact of balloon-expandable versus self-expandable transcatheter aortic valve implantation in French patients with aortic stenosis.1 We may agree with the general message that the clinical impact of echocardiographic gradients, areas, and leaks post–transcatheter aortic valve replacement (TAVR) is at best controversial, but this comment does not directly apply to our study. Our study was based on administrative data with information from diagnoses coded using International Classification of Diseases–10 and the French classification of medical procedures. Our analysis was restricted to the variables present in the database, which meant that echocardiography characteristics such as mean gradient, valve area, calcification, and paravalvular leak were not available for analysis, and we made no assumptions on the issues mentioned by Dr Abbas. Similarly, it is inappropriate to include our reference for a statement such as “echocardiographic gradient...does not translate into a clinically meaningful outcome with both older and newer generation devices” because we only included patients treated with newer generation devices (Evolut R and Sapiens 3). In our comments, we only proposed as a possible explanation that the higher risk of rehospitalization for heart failure with self-expandable valves might be related, among others, to a higher rate of paravalvular leak frequently reported by others with self-expandable valves.2,3 We agree that echography parameters after transcatheter aortic valve replacement implantation remain only surrogate end points to predict clinical outcomes. Our large population allowed us to analyze mortality, which is the ultimate end point after cardiac intervention. We would appreciate that our message remain as clear as possible. Our analysis included the largest cohort of latest-generation balloon-expandable versus self-expandable valves used for transcatheter aortic valve replacement. Balloon-expandable technology was associated with lower incidence rates of hard clinical end point (all-cause and cardiovascular death, and rehospitalization for heart failure), beyond the analysis of any echocardiographic end point. For what pertains to our study, it is inaccurate to state that our results were obtained “after adjusting for echocardiographic paravalvular leak and despite a residual higher gradient with balloon-expandable valves versus selfexpandable valves.”